Nalbuphine

Drug Levels and Effects:




Summary of Use during Lactation:


Limited data indicate that nalbuphine is excreted into breastmilk in small amounts. Because nalbuphine has poor oral absorption, it is unlikely to adversely affect the breastfed infant. No special precautions are required.


Drug Levels:


In adults, nalbuphine has very poor oral bioavailability and is metabolized to inactive metabolites. Parenteral doses of 75 to 300 mcg/kg are used in infant and children.

Maternal Levels.

Seven women who were 3 to 7 days postpartum received a single 20 mg IM dose of nalbuphine. Milk samples were collected several times beginning at 1 hour and finishing at 24 hours after the dose. The half-life of elimination from milk was about 8 hours. A reported peak milk level in one mother was about 25 mcg/L and it occurred 1 hour after the dose. The average milk level over the 24 hour study period in all 7 mothers was about 5 mcg/L (range 1.5 to 20 mcg/L).[1] Using the peak level reported in this study, an exclusively breastfed infant would receive a dosage of 3.7 mcg/kg daily, equivalent to 1.1 % of the maternal weight-adjusted dosage. Using the average milk level from this study, an exclusively breastfed infant would ingest 0.75 mcg/kg daily, equivalent to 0.2% of the maternal weight-adjusted dosage or 0.25 to 1% of the infant parenteral dosage.

Eighteen women were administered nalbuphine 0.2 mg/kg intravenously every 4 hours (average 25.5 mcg/kg daily) for pain following cesarean section. Milk samples were collected every 3 hours during the second day of drug administration. Because of small milk volumes, only 32 samples from 14 of the women were collected. The average milk nalbuphine concentration was 42 mcg/L, and the average maximum milk concentration was 61 mcg/L. The authors estimated that a fully breastfed infant would receive an average of 7 mcg/kg daily which amounts to about 0.6% of the weight-adjusted maternal dosage.[2]




Effects in Breastfed Infants:


Relevant published information was not found as of the revision date.


Possible Effects on Lactation:


Nalbuphine can increase serum prolactin.[3] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

A study compared women who received nalbuphine or butorphanol during labor (n = 26) to those who received no analgesia (n = 22). The time to effective breastfeeding was longer (46.5 minutes) in the analgesia group than in the no analgesia group (35.4 minutes).[4]


Alternate Drugs to Consider:


Acetaminophen,Ibuprofen,Butorphanol,Morphine


References:


1. Wischnik A, Wetzelsberger N, Lucker PW. [Elimination von nalbuphin in die muttermilch [Elimination of nalbuphine in human milk]. Arzneimittelforschung. 1988;38:1496-8. PMID:3196391
2. Jacqz-Aigrain E, Serreau R, Boissinot C, Popon MJ et al. Excretion of ketoprofen and nalbuphine in human milk during treatment of maternal pain after delivery. Ther Drug Monit. 2007;29:815-8. PMID:18043481
3. Saarialho-Kere U. Psychomotor, respiratory and neuroendocrinological effects of nalbuphine and haloperidol, alone and in combination, in healthy subjects. Br J Clin Pharmacol. 1988;26:79-87. PMID:3060191



Substance Identification:




Substance Name:

Nalbuphine

CAS Registry Number:

20594-83-6

Drug Class:


  • Analgesics, Opioid

  • Narcotics

  • Narcotic Antagonists


  • Administrative Information:




    LactMed Record Number:


    371


    Last Revision Date:


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